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Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.
This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease with and without fatigue. These results will be compared to an age- and gender matched control group with a comparable tumor disease and to another age- and gender matched control group without tumor disease.
The investigators are following the same strategy for investigating an underlying pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age- and gender matched control group will be established from the beforementioned control group.
The investigators will also be screening for a peritoneal microbiome (possible correlate for leaky gut) in study patients undergoing abdominal surgery.
We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome by double-blinded, placebo-controlled administration of probiotics to the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Tumor disease w/o fatigue | Active Comparator | Group receiving probiotics. |
|
| Arm 2: Tumor disease w/o fatigue | Placebo Comparator | Group receiving placebo (corn starch) |
|
| Arm 3: Healthy control group | Active Comparator | Group receiving probiotics |
|
| Arm 4: Healthy control group | Placebo Comparator | Group receiving placebo (corn starch) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | The administered probiotics are readily available on the market and contain
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement of fatigue symptoms | Improvement of fatigue as measured by validated psychometric questionnaires. | 3 months after end of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Jelden, MD | Contact | +4968411630000 | michael.jelden@uks.eu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Jelden, MD | University Hospital, Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saarland University Medical Center | Recruiting | Homburg | Saarland | 66424 | Germany |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double blinded, placebo controlled intervention with probiotics
There are three groups in the study:
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Blinding will be made at the probiotics manufacturer's establishment. Neither investigators nor care providers nor patients know their status til the end of the study.
|
| Placebo | Dietary Supplement | Identically looking to verum, containing corn starch. |
|
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |